Weekly Digest – June 2026 Weekly Digest – June 2026 17 June 2026: FDA Accepts sBLA for Genentech’s Lunsumio and Polivy combination in relapsed/refractory Large B-cell lymphoma Genentech has announced that the U.S. FDA has accepted a supplemental Biologics License […]
Weekly Digest – June 2026 Weekly Digest – June 2026 12 June 2026: Oncopeptides submits EMA application for Pepaxti label expansion to third-line treatment Oncopeptides has submitted a type 2 variation application to the European Medicines Agency seeking to expand […]
Weekly Digest – June 2026 Weekly Digest – June 2026 17 June 2026: Henlius’ HLX43 in combination with Serplulimab phase 2 NSCLC trial approved in Australia Henlius has received approval from Australia’s Human Research Ethics Committee, with acknowledgment from the […]
Weekly Digest – June 2026 Weekly Digest – June 2026 08 June 2026: China NMPA grants IND clearance to ADRX-0405 for advanced Solid tumors including Prostate cancer Adcentrx Therapeutics has received Investigational New Drug clearance from China’s National Medical Products […]
Weekly Digest – June 2026 Weekly Digest – June 2026 04 June 2026: Innovent Biologics’ IBI343 met primary endpoint in phase 3 Gastric cancer trial with NDA accepted by NMPA Innovent Biologics has announced that IBI343, a CLDN18.2-targeted antibody-drug conjugate, […]
Weekly Digest – June 2026 Weekly Digest – June 2026 03 June 2026: SOTIO receives U.S. FDA Orphan Drug Designation for SOT106, a potential best-in-class ADC for Sarcoma SOTIO announced that the U.S. FDA has granted Orphan Drug Designation to […]
Weekly Digest – May 2026 Weekly Digest – May 2026 22 May 2026: CHMP recommends EU approval of Enhertu for previously treated HER2-positive metastatic Solid tumours AstraZeneca and Daiichi Sankyo have received a positive CHMP opinion for Enhertu in previously […]
Weekly Digest – May 2026 Weekly Digest – May 2026 22 May 2026: Gilead receives CHMP positive opinion for Trodelvy in 1L metastatic TNBC patients ineligible for PD-(L)1 inhibitors Gilead has received a positive CHMP opinion for Trodelvy in the […]
Weekly Digest – May 2026 Weekly Digest – May 2026 25 May 2026: Sino Biopharmaceuticals CLDN18.2 ADC LM-302 granted Priority Review with China approval expected Sino Biopharmaceuticals CLDN18.2-targeted ADC LM-302 has entered China’s priority review pathway, positioning the asset for […]
Weekly Digest – May 2026 Weekly Digest – May 2026 22 May 2026: PADCEV in combination with Keytruda receives positive CHMP opinion for the treatment of patients with resectable MIBC who are ineligible for cisplatin-based chemotherapy Astellas Pharma announced that […]
